US2019038498A1PendingUtilityA1

Methods of treating and preventing disease by clamping of skin

45
Assignee: NATURAL PHARMACIA INT INCPriority: Mar 1, 2016Filed: Feb 28, 2017Published: Feb 7, 2019
Est. expiryMar 1, 2036(~9.6 yrs left)· nominal 20-yr term from priority
B25B 7/18A61B 17/28A61H 7/00A61B 2017/2808A61B 17/122
45
PatentIndex Score
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Claims

Abstract

The invention provides methods of treating diseases, such as various cancers, neoplasms, autoimmune diseases, and infectious diseases, among others, by clamping the skin of a subject in need of treatment so as to apply a compressive force that is sufficient to cause damage, often manifested in pain or bruising, to the underlying tissue. The invention additionally provides kits containing clamps capable of regulating the distance between the arms of the clamp such that a user of the clamp will apply a safe amount of pressure to the skin of a subject that is sufficient to cause tissue bruising and/or pain.

Claims

exact text as granted — not AI-modified
1 . A method of treating a disease in a subject, said method comprising enclosing a portion of tissue comprising skin of said subject within a clamp and clamping the tissue for a duration and with sufficient pressure to cause damage to said tissue. 
     
     
         2 . The method of  claim 1 , wherein the method comprises folding said portion to form a crease prior to said enclosing. 
     
     
         3 . The method of  claim 2 , wherein the folding comprises lifting said skin to form a region of skin that is convex with respect to surrounding skin that is not folded. 
     
     
         4 . The method of any one of  claims 1 - 3 , wherein the portion of tissue comprises one or more tumors. 
     
     
         5 . The method of  claim 4 , wherein the clamping causes crushing of said one or more tumors. 
     
     
         6 . The method of any one of  claims 1 - 5 , wherein the method further comprises compressing one or more muscles and/or connective tissues located underneath said skin. 
     
     
         7 . The method of any one of  claims 1 - 6 , wherein the pressure is applied at a location at which said skin converges with surrounding skin that is not folded. 
     
     
         8 . The method of any one of  claims 1 - 7 , wherein the clamp comprises curved ends and a flexible handle. 
     
     
         9 . The method of  claim 8 , wherein the flexible handle is configured to allow a user of said clamp to control the duration of pressure applied by said clamping. 
     
     
         10 . The method of  claim 8  or  9 , wherein the flexible handle is configured to allow a user of said clamp to control the amount of pressure applied by said clamping. 
     
     
         11 . The method of any one of  claims 1 - 10 , wherein the clamp comprises a mechanism capable of regulating distance between said curved ends. 
     
     
         12 . The method of any one of  claims 1 - 11 , wherein the clamp comprises arms and a regulator screw capable of maintaining a desired distance between the arms of the clamp. 
     
     
         13 . The method of  claim 12 , wherein the regulator screw can be adjusted to one of a plurality of settings. 
     
     
         14 . The method of  claim 13 , wherein the plurality of settings correspond to a state of maximum distance between the arms of the clamp, one or more states of intermediate distance between the arms of the clamp, and a state of minimum distance between the arms of the clamp. 
     
     
         15 . The method of  claim 14 , wherein the maximum distance is between about 2.4 cm and about 7.2 cm. 
     
     
         16 . The method of  claim 14 , wherein the intermediate distance is between about 1.6 cm and about 4.8 cm. 
     
     
         17 . The method of  claim 14 , wherein the minimum distance is between about 0.8 and about 2.4 cm. 
     
     
         18 . The method of any one of  claims 14 - 17 , wherein the setting that corresponds to the state of maximum distance between the arms of the clamp is indicated by exposure of a green color adjacent to an arm of the clamp. 
     
     
         19 . The method of any one of  claims 14 - 18 , wherein the setting that corresponds to said state of intermediate distance between the arms of said clamp is indicated by exposure of a yellow color adjacent to an arm of said clamp. 
     
     
         20 . The method of any one of  claims 14 - 19 , wherein the setting that corresponds to said state of minimum distance between the arms of said clamp is indicated by exposure of a red color adjacent to an arm of said clamp. 
     
     
         21 . The method of any one of  claims 1 - 20 , wherein the clamping occurs for a period of about 1 to about 10 seconds. 
     
     
         22 . The method of  claim 21 , wherein the clamping occurs for a period of about 1 to about 3 seconds. 
     
     
         23 . The method of any one of  claims 1 - 22 , wherein the clamping is performed one or more times daily, weekly, monthly, or yearly. 
     
     
         24 . The method of  claim 23 , wherein the clamping is performed one or more times daily. 
     
     
         25 . The method of  claim 24 , wherein the clamping is performed one or more times daily for between about two and about twenty days. 
     
     
         26 . The method of  claim 25 , wherein the clamping is performed one or more times daily for six days. 
     
     
         27 . The method of  claim 26 , wherein at the end of said six days, the clamping is repeated one or more times every other day for a total of  16  additional days to form a standard treatment course. 
     
     
         28 . The method of  claim 27 , wherein the standard treatment course is repeated between two and twenty times. 
     
     
         29 . The method of  claim 28 , wherein the standard treatment course is repeated between five and fifteen times. 
     
     
         30 . The method of  claim 29 , wherein the standard treatment course is repeated between six and nine times. 
     
     
         31 . The method of  claim 30 , wherein the standard treatment course is repeated seven times. 
     
     
         32 . The method of  claim 30 , wherein the standard treatment course is repeated eight times. 
     
     
         33 . The method of any one of  claims 27 - 32 , wherein the clamping is performed with increasing pressure over the duration of said standard treatment course. 
     
     
         34 . The method of any one of  claims 1 - 33 , wherein the clamping is sufficient to cause pain and/or bruising to said tissue. 
     
     
         35 . The method of any one of  claims 1 - 34 , wherein the clamping causes an increase in the amount or concentration of one or more antigens on the surface of a cancer cell within said subject. 
     
     
         36 . The method of any one of  claims 1 - 35 , wherein the clamping causes an increase in the amount or concentration of one or more dendritic cells on the surface of a cancer cell within said subject. 
     
     
         37 . The method of  claim 36 , wherein the dendritic cells are located below said skin. 
     
     
         38 . The method of any one of  claims 1 - 37 , wherein the subject exhibits an elevated immune response after said clamping is performed. 
     
     
         39 . The method of  claim 38 , wherein the elevated immune response is selected from the group consisting of inflammation, secretion of chemokines, an increase in the level of one or more cytokines, and activation of one or more immune cells within said subject. 
     
     
         40 . The method of  claim 39 , wherein the inflammation comprises one or more processes selected from the group consisting of arteriole dilation, an increase in capillary permeability, and migration of neutrophils and/or macrophages from capillaries or venules into interstitial spaces. 
     
     
         41 . The method of  claim 39 , wherein the chemokines are capable of attracting to said portion of tissue one or more macrophages, T-cells, mast cells, dendritic cells, activated dendritic cells, eosinophils, and/or neutrophils. 
     
     
         42 . The method of  claim 39 , wherein the one or more cytokines are selected from the group consisting of TNFα, IFNγ, IL-1, IL-6, and IL-8. 
     
     
         43 . The method of  claim 39 , wherein the one or more immune cells are selected from the group consisting of macrophages, neutrophils, T-cells, antigen-presenting cells, and dendritic cells. 
     
     
         44 . The method of any one of  claims 1 - 43 , wherein the subject exhibits epidermal lumps after said clamping is performed. 
     
     
         45 . The method of  claim 44 , wherein the lumps are between about 1 cm and about 3 cm in length. 
     
     
         46 . The method of  claim 44  or  45 , wherein the method further comprising the step of compressing said lumps. 
     
     
         47 . The method of  claim 46 , wherein the lumps are broken into a plurality of fragments. 
     
     
         48 . The method of  claim 46  or  47 , wherein the lumps comprise cell debris. 
     
     
         49 . The method of  claim 48 , wherein the cell debris is or comprises monosodium urate. 
     
     
         50 . The method of  claim 49 , wherein the monosodium urate is in a crystalline form. 
     
     
         51 . The method of  claim 49  or  50 , wherein the monosodium urate is released within said subject. 
     
     
         52 . The method of  claim 51 , wherein the monosodium urate is released into peripheral tissues within said subject. 
     
     
         53 . The method of any one of  claims 49 - 52 , wherein the monosodium urate promotes the growth or maturation of one or more cells selected from the group consisting of macrophages, neutrophils, T-cells, antigen-presenting cells, and dendritic cells. 
     
     
         54 . The method of any one of  claims 49 - 53 , wherein the monosodium urate induces the production of IL-1β in said subject. 
     
     
         55 . The method of any one of  claims 41 ,  43 , and  53 , wherein the T-cells are CD4+ or CD8+ T-cells. 
     
     
         56 . The method of any one of  claims 41 ,  43 ,  53 , and  55 , wherein the T-cells are capable of specifically binding an antigen expressed on the surface of a cancer cell. 
     
     
         57 . The method of  claim 56 , wherein the T-cells are capable of killing one or more of said cancer cells. 
     
     
         58 . The method of any one of  claims 1 - 57 , wherein the skin is located along a meridian line of said subject. 
     
     
         59 . The method of  claim 58 , wherein the meridian line is selected from the group consisting of wood phase meridian, first fire phase meridian, second fire phase meridian, earth phase meridian, metal phase meridian, water phase meridian, lung meridian, heart meridian, liver meridian, spleen meridian, kidney meridian, pericardium meridian, large intestine meridian, small intestine meridian, stomach meridian, bladder meridian, and gall bladder meridian. 
     
     
         60 . The method of any one of  claims 1 - 59 , wherein the disease is a cancer. 
     
     
         61 . The method of  claim 60 , wherein the cancer is selected from the group consisting of leukemia, lymphoma, liver cancer, bone cancer, skin cancer, pulmonary cancer, brain cancer, bladder cancer, gastrointestinal cancer, breast cancer, cardiac cancer, cervical cancer, uterine cancer, head and neck cancer, gallbladder cancer, laryngeal cancer, lip and oral cavity cancer, ocular cancer, melanoma, pancreatic cancer, prostate cancer, colorectal cancer, testicular cancer, throat cancer, adenocarcinoma, pituitary adenoma, acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), adrenocortical carcinoma, AIDS-related lymphoma, primary CNS lymphoma, anal cancer, appendix cancer, astrocytoma, atypical teratoid/rhabdoid tumor, basal cell carcinoma, bile duct cancer, extrahepatic cancer, ewing sarcoma family, osteosarcoma and malignant fibrous histiocytoma, central nervous system embryonal tumors, central nervous system germ cell tumors, craniopharyngioma, ependymoma, bronchial tumors, burkitt lymphoma, carcinoid tumor, primary lymphoma, chordoma, chronic myeloproliferative neoplasms, colon cancer, extrahepatic bile duct cancer, ductal carcinoma in situ (DCIS), endometrioma, ependymoma, esophageal cancer, esthesioneuroblastoma, extracranial germ cell tumor, extragonadal germ cell tumor, fallopian tube cancer, fibrous histiocytoma of bone, gastrointestinal carcinoid tumor, gastrointestinal stromal tumors (GIST), testicular germ cell tumor, gestational trophoblastic disease, glioma, childhood brain stem glioma, hairy cell leukemia, hepatocellular cancer, langerhans cell histiocytosis, hodgkin lymphoma, hypopharyngeal cancer, islet cell tumors, pancreatic neuroendocrine tumors, wilms tumor and other childhood kidney tumors, langerhans cell histiocytosis, small cell lung cancer, cutaneous T-cell lymphoma, intraocular melanoma, merkel cell carcinoma, mesothelioma, metastatic squamous neck cancer, midline tract carcinoma, multiple endocrine neoplasia syndromes, multiple myeloma/plasma cell neoplasm, myelodysplastic syndromes, nasal cavity and paranasal sinus cancer, nasopharyngeal cancer, neuroblastoma, non-hodgkin lymphoma (NHL), non-small cell lung cancer (NSCLC), ovarian carcinoma, low malignant potential ovarian cancer, pancreatic neuroendocrine tumors, papillomatosis, paraganglioma, paranasal sinus and nasal cavity cancer, parathyroid cancer, penile cancer, pharyngeal cancer, pheochromocytoma, pituitary tumor, pleuropulmonary blastoma, primary peritoneal cancer, rectal cancer, retinoblastoma, rhabdomyosarcoma, salivary gland cancer, kaposi sarcoma, rhabdomyosarcoma, sézary syndrome, small intestine cancer, soft tissue sarcoma, throat cancer, thymoma and thymic carcinoma, thyroid cancer, transitional cell cancer of the renal pelvis and ureter, urethral cancer, uterine sarcoma, vaginal cancer, vulvar cancer, and waldenström macroglobulinemia. 
     
     
         62 . The method of  claim 60 , wherein the cancer is selected from the group consisting of breast cancer, adenocarcinoma, leukemia, skin cancer, ovarian carcinoma, pituitary adenoma, pulmonary cancer, endometrioma, and cervical cancer. 
     
     
         63 . The method of  claim 62 , wherein the breast cancer is selected from the group consisting of late stage breast cancer, bilateral breast ductal carcinoma, and invasive bilateral breast cancer. 
     
     
         64 . The method of any one of  claims 1 - 59 , wherein the disease is a neoplasm. 
     
     
         65 . The method of  claim 64 , wherein the neoplasm is a growth of a tissue or organ selected the group consisting of a pancreas, salivary gland, pituitary gland, kidney, heart, lung, hematopoietic system, cranial nerves, heart, aorta, olfactory gland, hypopharynx, ear, nerves, structures of the head, eye, thymus, tongue, bone, liver, small intestine, large intestine, gut, brain, skin, peripheral nervous system, central nervous system, spinal cord, breast, embryonic structures, embryos, and testes. 
     
     
         66 . The method of  claim 65 , wherein the neoplasm is a growth of an organ selected from the group consisting of a lung, kidney, and hypopharynx. 
     
     
         67 . The method of any one of  claims 1 - 59 , wherein the disease is an autoimmune disease selected from the group consisting of type I diabetes, alopecia areata, ankylosing spondylitis, antiphospholipid syndrome, autoimmune Addison's Disease, autoimmune hemolytic anemia, autoimmune hepatitis, Behcet's Disease, bullous pemphigoid, cardiomyopathy, celiac sprue-dermatitis, chronic fatigue immune dysfunction syndrome (CFIDS), chronic inflammatory demyelinating polyneuropathy, Churg-Strauss Syndrome, cicatricial pemphigoid, crest syndrome, cold agglutinin disease, Crohn's Disease, essential mixed cryoglobulinemia, fibromyalgia-fibromyositis, Graves' Disease, Guillain-Barré Syndrome, Hashimoto's thyroiditis, hypothyroidism, idiopathic pulmonary fibrosis, idiopathic thrombocytopenia purpura (ITP), IgA nephropathy, juvenile arthritis, lichen planus, lupus, systemic lupus erythematosus, Ménière's Disease, mixed connective tissue disease, multiple sclerosis, myasthenia gravis, pemphigus vulgaris, pernicious anemia, polyarteritis nodosa, polychondritis, polyglandular syndromes, polymyalgia rheumatica, polymyositis and dermatomyositis, primary agammaglobulinemia, primary biliary cirrhosis, psoriasis, Raynaud's Phenomenon, Reiter's Syndrome, rheumatic fever, rheumatoid arthritis, sarcoidosis, scleroderma, Sjögren's Syndrome, stiff-man syndrome, Takayasu Arteritis, temporal arteritis/giant cell arteritis, ulcerative colitis, uveitis, vasculitis, vitiligo, and Wegener's Granulomatosis. 
     
     
         68 . The method of  claim 67 , wherein the autoimmune disease is selected from the group consisting of type I diabetes and lupus. 
     
     
         69 . The method of any one of  claims 1 - 59 , wherein the disease is an infectious disease caused by one or more agents selected from the group consisting of a virus, a bacterium, a fungus, or a parasite. 
     
     
         70 . The method of  claim 69 , wherein the virus is selected from the group consisting of Gadgets Gully virus, Kadam virus, Kyasanur Forest disease virus, Langat virus, Omsk hemorrhagic fever virus, Powassan virus, Royal Farm virus, tick-borne encephalitis virus, Louping ill virus, Meaban virus, Saumarez Reef virus, Tyuleniy virus, Aroa virus, dengue virus, Kedougou virus, Cacipacore virus, Koutango virus, Japanese encephalitis virus, Murray Valley encephalitis virus, St. Louis encephalitis virus, Usutu virus, West Nile virus, Yaounde virus, Kokobera virus, Bagaza virus, Ilheus virus, Israel turkey meningoencephalo-myelitis virus, Ntaya virus, Tembusu virus, Zika virus, Banzi virus, Bouboui virus, Edge Hill virus, Jugra virus, Saboya virus, Sepik virus, Uganda S virus, Wesselsbron virus, yellow fever virus, Entebbe bat virus, Yokose virus, Apoi virus, Cowbone Ridge virus, Jutiapa virus, Modoc virus, Sal Vieja virus, San Perlita virus, Bukalasa bat virus, Carey Island virus, Dakar bat virus, Montana myotis leukoencephalitis virus, Phnom Penh bat virus, and Rio Bravo virus, Venezuelan equine encephalitis virus (VEE), Eastern equine encephalitis virus (EEE), Western equine encephalitis virus (WEE), Ebola virus, Marburg virus, smallpox virus, vaccinia virus, Lassa virus, Ippy virus, lymphocytic choriomeningitis virus (LCMV), Mobala virus, Mopeia virus, Amapari virus, Flexal virus, Guanarito virus, Junin virus, Latino virus, Machupo virus, Oliveros virus, Paraná virus, Pichinde virus, Pirital virus, Sabiá virus, Tacaribe virus, Tamiami virus, and Whitewater Arroyo virus, Sin Nombre virus, Hantaan virus, Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus, Dugbe virus, herpes simplex virus (HSV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), Kaposi's sarcoma associated-herpesvirus (KSHV), influenzavirus A, H5N1 avian influenza virus, influenzavirus B, influenzavirus C, severe acute respiratory syndrome (SARS) virus, rabies virus, and vesicular stomatitis virus (VSV). 
     
     
         71 . The method of  claim 69 , wherein the bacterium is selected from the group consisting of  Pseudomonas aeruginosa, Salmonella typhimurium, Escherichia coli, Klebsiella pneumoniae, Bruscella, Burkholderia mallei, Yersinia pestis,  and  Bacillus anthracis.    
     
     
         72 . The method of  claim 69 , wherein the fungus is selected from the group consisting of  Aspergillus, Blastomyces dermatitidis, Candida, Coccidioides immitis, Cryptococcus neoformans, Histoplasma capsulatum var. capsulatum, Paracoccidioides brasiliensis, Sporothrix schenckii, Zygomycetes  spp.,  Absidia corymbifera, Rhizomucor pusillus,  and  Rhizopus arrhizus.    
     
     
         73 . The method of  claim 69 , wherein the parasite is selected from the group consisting of  Toxoplasma gondii, Plasmodium falciparum, P. vivax, P. ovale, P. malariae, Trypanosoma  spp., and  Legionella  spp. 
     
     
         74 . The method of any one of  claims 1 - 59 , wherein the disease is selected from the group consisting of hypertension, hyperglycemia, hyperlipidemia, edema, depression, obesity, infertility, amenorrhea, fatigue, vertigo, uterine bleeding, uterine ulcer, hyperthyroidism, myoma, endometriosis, cerebral palsy, brain atrophy, systemic muscular atrophy, trigeminal neuralgia, schizophrenia, epilepsy, amyotrophic lateral sclerosis (ALS), Parkinson's Disease, autism, Alzheimer's Disease, Huntington's Disease, emphysema, asthma, hepatitis B, cough, systemic fibroma, renal diseases, lung diseases, and liver diseases. 
     
     
         75 . The method of any one of  claims 1 - 74 , wherein the subject is a mammal. 
     
     
         76 . The method of  claim 75 , wherein the mammal is a human. 
     
     
         77 . A kit comprising a clamp and a package insert instructing a user of said kit to treat a subject according to the method of any one of  claims 1 - 76 . 
     
     
         78 . The kit of  claim 77 , wherein the clamp comprises a regulator screw capable of maintaining a desired distance between arms of said clamp. 
     
     
         79 . The kit of  claim 78 , wherein the regulator screw can be adjusted to one of a plurality of settings. 
     
     
         80 . The kit of  claim 79 , wherein the plurality of settings correspond to a state of maximum distance between the arms of said clamp, one or more states of intermediate distance between the arms of said clamp, and a state of minimum distance between the arms of said clamp. 
     
     
         81 . The kit of  claim 80 , wherein the setting that corresponds to said state of maximum distance between the arms of said clamp is indicated by exposure of a green color adjacent to an arm of said clamp. 
     
     
         82 . The kit of  claim 80 , wherein the setting that corresponds to said state of intermediate distance between the arms of said clamp is indicated by exposure of a yellow color adjacent to an arm of said clamp. 
     
     
         83 . The kit of  claim 80 , wherein the setting that corresponds to said state of minimum distance between the arms of said clamp is indicated by exposure of a red color adjacent to an arm of said clamp. 
     
     
         84 . The method of  claim 1 , wherein the portion of tissue comprises one or more tumors. 
     
     
         85 . The method of  claim 84 , wherein the clamping causes crushing of said one or more tumors. 
     
     
         86 . The method of  claim 1 , wherein the method further comprises compressing one or more muscles and/or connective tissues located underneath said skin. 
     
     
         87 . The method of  claim 1 , wherein the pressure is applied at a location at which said skin converges with surrounding skin that is not folded. 
     
     
         88 . The method of  claim 1 , wherein the clamp comprises curved ends and a flexible handle. 
     
     
         89 . The method of  claim 88 , wherein the flexible handle is configured to allow a user of said clamp to control the duration of pressure applied by said clamping. 
     
     
         90 . The method of  claim 88  or  89 , wherein the flexible handle is configured to allow a user of said clamp to control the amount of pressure applied by said clamping. 
     
     
         91 . The method of  claim 1 , wherein the clamp comprises a mechanism capable of regulating distance between said curved ends. 
     
     
         92 . The method of  claim 1 , wherein the clamp comprises arms and a regulator screw capable of maintaining a desired distance between the arms of the clamp. 
     
     
         93 . The method of  claim 92 , wherein the regulator screw can be adjusted to one of a plurality of settings. 
     
     
         94 . The method of  claim 93 , wherein the plurality of settings correspond to a state of maximum distance between the arms of the clamp, one or more states of intermediate distance between the arms of the clamp, and a state of minimum distance between the arms of the clamp. 
     
     
         95 . The method of  claim 94 , wherein the maximum distance is between about 2.4 cm and about 7.2 cm. 
     
     
         96 . The method of  claim 94 , wherein the intermediate distance is between about 1.6 cm and about 4.8 cm. 
     
     
         97 . The method of  claim 94 , wherein the minimum distance is between about 0.8 and about 2.4 cm. 
     
     
         98 . The method of any one of  claims 94 - 97 , wherein the setting that corresponds to the state of maximum distance between the arms of the clamp is indicated by exposure of a green color adjacent to an arm of the clamp. 
     
     
         99 . The method of  claim 94 , wherein the setting that corresponds to said state of intermediate distance between the arms of said clamp is indicated by exposure of a yellow color adjacent to an arm of said clamp. 
     
     
         100 . The method of  claim 94 , wherein the setting that corresponds to said state of minimum distance between the arms of said clamp is indicated by exposure of a red color adjacent to an arm of said clamp. 
     
     
         101 . The method of  claim 1 , wherein the clamping occurs for a period of about 1 to about 10 seconds. 
     
     
         102 . The method of  claim 101 , wherein the clamping occurs for a period of about 1 to about 3 seconds. 
     
     
         103 . The method of  claim 1 , wherein the clamping is performed one or more times daily, weekly, monthly, or yearly. 
     
     
         104 . The method of  claim 103 , wherein the clamping is performed one or more times daily. 
     
     
         105 . The method of  claim 104 , wherein the clamping is performed one or more times daily for between about two and about twenty days. 
     
     
         106 . The method of  claim 105 , wherein the clamping is performed one or more times daily for six days. 
     
     
         107 . The method of  claim 106 , wherein at the end of said six days, the clamping is repeated one or more times every other day for a total of  16  additional days to form a standard treatment course. 
     
     
         108 . The method of  claim 107 , wherein the standard treatment course is repeated between two and twenty times. 
     
     
         109 . The method of  claim 108 , wherein the standard treatment course is repeated between five and fifteen times. 
     
     
         110 . The method of  claim 109 , wherein the standard treatment course is repeated between six and nine times. 
     
     
         111 . The method of  claim 110 , wherein the standard treatment course is repeated seven times. 
     
     
         112 . The method of  claim 110 , wherein the standard treatment course is repeated eight times. 
     
     
         113 . The method of  claim 107 , wherein the clamping is performed with increasing pressure over the duration of said standard treatment course. 
     
     
         114 . The method of  claim 1 , wherein the clamping is sufficient to cause pain and/or bruising to said tissue. 
     
     
         115 . The method of  claim 1 , wherein the clamping causes an increase in the amount or concentration of one or more antigens on the surface of a cancer cell within said subject. 
     
     
         116 . The method of  claim 1 , wherein the clamping causes an increase in the amount or concentration of one or more dendritic cells on the surface of a cancer cell within said subject. 
     
     
         117 . The method of  claim 116 , wherein the dendritic cells are located below said skin. 
     
     
         118 . The method of  claim 1 , wherein the subject exhibits an elevated immune response after said clamping is performed. 
     
     
         119 . The method of  claim 118 , wherein the elevated immune response is selected from the group consisting of inflammation, secretion of chemokines, an increase in the level of one or more cytokines, and activation of one or more immune cells within said subject. 
     
     
         120 . The method of  claim 119 , wherein the inflammation comprises one or more processes selected from the group consisting of arteriole dilation, an increase in capillary permeability, and migration of neutrophils and/or macrophages from capillaries or venules into interstitial spaces. 
     
     
         121 . The method of  claim 119 , wherein the chemokines are capable of attracting to said portion of tissue one or more macrophages, T-cells, mast cells, dendritic cells, activated dendritic cells, eosinophils, and/or neutrophils. 
     
     
         122 . The method of  claim 119 , wherein the one or more cytokines are selected from the group consisting of TNFα, IFNγ, IL-1, IL-6, and IL-8. 
     
     
         123 . The method of  claim 119 , wherein the one or more immune cells are selected from the group consisting of macrophages, neutrophils, T-cells, antigen-presenting cells, and dendritic cells. 
     
     
         124 . The method of  claim 1 , wherein the subject exhibits epidermal lumps after said clamping is performed. 
     
     
         125 . The method of  claim 124 , wherein the lumps are between about 1 cm and about 3 cm in length. 
     
     
         126 . The method of  claim 124  or  125 , wherein the method further comprising the step of compressing said lumps. 
     
     
         127 . The method of  claim 126 , wherein the lumps are broken into a plurality of fragments. 
     
     
         128 . The method of  claim 126  or  127 , wherein the lumps comprise cell debris. 
     
     
         129 . The method of  claim 128 , wherein the cell debris is or comprises monosodium urate. 
     
     
         130 . The method of  claim 129 , wherein the monosodium urate is in a crystalline form. 
     
     
         131 . The method of  claim 129  or  130 , wherein the monosodium urate is released within said subject. 
     
     
         132 . The method of  claim 131 , wherein the monosodium urate is released into peripheral tissues within said subject. 
     
     
         133 . The method of  claim 129 , wherein the monosodium urate promotes the growth or maturation of one or more cells selected from the group consisting of macrophages, neutrophils, T-cells, antigen-presenting cells, and dendritic cells. 
     
     
         134 . The method of  claim 129 , wherein the monosodium urate induces the production of IL- 1   R  in said subject. 
     
     
         135 . The method of  claim 121 , wherein the T-cells are CD4+ or CD8+ T-cells. 
     
     
         136 . The method of  claim 121 , wherein the T-cells are capable of specifically binding an antigen expressed on the surface of a cancer cell. 
     
     
         137 . The method of  claim 136 , wherein the T-cells are capable of killing one or more of said cancer cells. 
     
     
         138 . The method of  claim 1 , wherein the skin is located along a meridian line of said subject. 
     
     
         139 . The method of  claim 138 , wherein the meridian line is selected from the group consisting of wood phase meridian, first fire phase meridian, second fire phase meridian, earth phase meridian, metal phase meridian, water phase meridian, lung meridian, heart meridian, liver meridian, spleen meridian, kidney meridian, pericardium meridian, large intestine meridian, small intestine meridian, stomach meridian, bladder meridian, and gall bladder meridian. 
     
     
         140 . The method of  claim 1 , wherein the disease is a cancer. 
     
     
         141 . The method of  claim 140 , wherein the cancer is selected from the group consisting of leukemia, lymphoma, liver cancer, bone cancer, skin cancer, pulmonary cancer, brain cancer, bladder cancer, gastrointestinal cancer, breast cancer, cardiac cancer, cervical cancer, uterine cancer, head and neck cancer, gallbladder cancer, laryngeal cancer, lip and oral cavity cancer, ocular cancer, melanoma, pancreatic cancer, prostate cancer, colorectal cancer, testicular cancer, throat cancer, adenocarcinoma, pituitary adenoma, acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), adrenocortical carcinoma, AIDS-related lymphoma, primary CNS lymphoma, anal cancer, appendix cancer, astrocytoma, atypical teratoid/rhabdoid tumor, basal cell carcinoma, bile duct cancer, extrahepatic cancer, ewing sarcoma family, osteosarcoma and malignant fibrous histiocytoma, central nervous system embryonal tumors, central nervous system germ cell tumors, craniopharyngioma, ependymoma, bronchial tumors, burkitt lymphoma, carcinoid tumor, primary lymphoma, chordoma, chronic myeloproliferative neoplasms, colon cancer, extrahepatic bile duct cancer, ductal carcinoma in situ (DCIS), endometrioma, ependymoma, esophageal cancer, esthesioneuroblastoma, extracranial germ cell tumor, extragonadal germ cell tumor, fallopian tube cancer, fibrous histiocytoma of bone, gastrointestinal carcinoid tumor, gastrointestinal stromal tumors (GIST), testicular germ cell tumor, gestational trophoblastic disease, glioma, childhood brain stem glioma, hairy cell leukemia, hepatocellular cancer, langerhans cell histiocytosis, hodgkin lymphoma, hypopharyngeal cancer, islet cell tumors, pancreatic neuroendocrine tumors, wilms tumor and other childhood kidney tumors, langerhans cell histiocytosis, small cell lung cancer, cutaneous T-cell lymphoma, intraocular melanoma, merkel cell carcinoma, mesothelioma, metastatic squamous neck cancer, midline tract carcinoma, multiple endocrine neoplasia syndromes, multiple myeloma/plasma cell neoplasm, myelodysplastic syndromes, nasal cavity and paranasal sinus cancer, nasopharyngeal cancer, neuroblastoma, non-hodgkin lymphoma (NHL), non-small cell lung cancer (NSCLC), ovarian carcinoma, low malignant potential ovarian cancer, pancreatic neuroendocrine tumors, papillomatosis, paraganglioma, paranasal sinus and nasal cavity cancer, parathyroid cancer, penile cancer, pharyngeal cancer, pheochromocytoma, pituitary tumor, pleuropulmonary blastoma, primary peritoneal cancer, rectal cancer, retinoblastoma, rhabdomyosarcoma, salivary gland cancer, kaposi sarcoma, rhabdomyosarcoma, sézary syndrome, small intestine cancer, soft tissue sarcoma, throat cancer, thymoma and thymic carcinoma, thyroid cancer, transitional cell cancer of the renal pelvis and ureter, urethral cancer, uterine sarcoma, vaginal cancer, vulvar cancer, and waldenström macroglobulinemia. 
     
     
         142 . The method of  claim 140 , wherein the cancer is selected from the group consisting of breast cancer, adenocarcinoma, leukemia, skin cancer, ovarian carcinoma, pituitary adenoma, pulmonary cancer, endometrioma, and cervical cancer. 
     
     
         143 . The method of  claim 142 , wherein the breast cancer is selected from the group consisting of late stage breast cancer, bilateral breast ductal carcinoma, and invasive bilateral breast cancer. 
     
     
         144 . The method of  claim 1 , wherein the disease is a neoplasm. 
     
     
         145 . The method of  claim 144 , wherein the neoplasm is a growth of a tissue or organ selected the group consisting of a pancreas, salivary gland, pituitary gland, kidney, heart, lung, hematopoietic system, cranial nerves, heart, aorta, olfactory gland, hypopharynx, ear, nerves, structures of the head, eye, thymus, tongue, bone, liver, small intestine, large intestine, gut, brain, skin, peripheral nervous system, central nervous system, spinal cord, breast, embryonic structures, embryos, and testes. 
     
     
         146 . The method of  claim 145 , wherein the neoplasm is a growth of an organ selected from the group consisting of a lung, kidney, and hypopharynx. 
     
     
         147 . The method of  claim 1 , wherein the disease is an autoimmune disease selected from the group consisting of type I diabetes, alopecia areata, ankylosing spondylitis, antiphospholipid syndrome, autoimmune Addison's Disease, autoimmune hemolytic anemia, autoimmune hepatitis, Behcet's Disease, bullous pemphigoid, cardiomyopathy, celiac sprue-dermatitis, chronic fatigue immune dysfunction syndrome (CFIDS), chronic inflammatory demyelinating polyneuropathy, Churg-Strauss Syndrome, cicatricial pemphigoid, crest syndrome, cold agglutinin disease, Crohn's Disease, essential mixed cryoglobulinemia, fibromyalgia-fibromyositis, Graves' Disease, Guillain-Barré Syndrome, Hashimoto's thyroiditis, hypothyroidism, idiopathic pulmonary fibrosis, idiopathic thrombocytopenia purpura (ITP), IgA nephropathy, juvenile arthritis, lichen planus, lupus, systemic lupus erythematosus, Ménière's Disease, mixed connective tissue disease, multiple sclerosis, myasthenia gravis, pemphigus vulgaris, pernicious anemia, polyarteritis nodosa, polychondritis, polyglandular syndromes, polymyalgia rheumatica, polymyositis and dermatomyositis, primary agammaglobulinemia, primary biliary cirrhosis, psoriasis, Raynaud's Phenomenon, Reiter's Syndrome, rheumatic fever, rheumatoid arthritis, sarcoidosis, scleroderma, Sjögren's Syndrome, stiff-man syndrome, Takayasu Arteritis, temporal arteritis/giant cell arteritis, ulcerative colitis, uveitis, vasculitis, vitiligo, and Wegener's Granulomatosis. 
     
     
         148 . The method of  claim 147 , wherein the autoimmune disease is selected from the group consisting of type I diabetes and lupus. 
     
     
         149 . The method of  claim 1 , wherein the disease is an infectious disease caused by one or more agents selected from the group consisting of a virus, a bacterium, a fungus, or a parasite. 
     
     
         150 . The method of  claim 149 , wherein the virus is selected from the group consisting of Gadgets Gully virus, Kadam virus, Kyasanur Forest disease virus, Langat virus, Omsk hemorrhagic fever virus, Powassan virus, Royal Farm virus, tick-borne encephalitis virus, Louping ill virus, Meaban virus, Saumarez Reef virus, Tyuleniy virus, Aroa virus, dengue virus, Kedougou virus, Cacipacore virus, Koutango virus, Japanese encephalitis virus, Murray Valley encephalitis virus, St. Louis encephalitis virus, Usutu virus, West Nile virus, Yaounde virus, Kokobera virus, Bagaza virus, Ilheus virus, Israel turkey meningoencephalo-myelitis virus, Ntaya virus, Tembusu virus, Zika virus, Banzi virus, Bouboui virus, Edge Hill virus, Jugra virus, Saboya virus, Sepik virus, Uganda S virus, Wesselsbron virus, yellow fever virus, Entebbe bat virus, Yokose virus, Apoi virus, Cowbone Ridge virus, Jutiapa virus, Modoc virus, Sal Vieja virus, San Perlita virus, Bukalasa bat virus, Carey Island virus, Dakar bat virus, Montana myotis leukoencephalitis virus, Phnom Penh bat virus, and Rio Bravo virus, Venezuelan equine encephalitis virus (VEE), Eastern equine encephalitis virus (EEE), Western equine encephalitis virus (WEE), Ebola virus, Marburg virus, smallpox virus, vaccinia virus, Lassa virus, Ippy virus, lymphocytic choriomeningitis virus (LCMV), Mobala virus, Mopeia virus, Amapari virus, Flexal virus, Guanarito virus, Junin virus, Latino virus, Machupo virus, Oliveros virus, Paraná virus, Pichinde virus, Pirital virus, Sabiá virus, Tacaribe virus, Tamiami virus, and Whitewater Arroyo virus, Sin Nombre virus, Hantaan virus, Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus, Dugbe virus, herpes simplex virus (HSV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), Kaposi's sarcoma associated-herpesvirus (KSHV), influenzavirus A, H5N1 avian influenza virus, influenzavirus B, influenzavirus C, severe acute respiratory syndrome (SARS) virus, rabies virus, and vesicular stomatitis virus (VSV). 
     
     
         151 . The method of  claim 149 , wherein the bacterium is selected from the group consisting of  Pseudomonas aeruginosa, Salmonella typhimurium, Escherichia coli, Klebsiella pneumoniae, Bruscella, Burkholderia mallei, Yersinia pestis,  and  Bacillus anthracis.    
     
     
         152 . The method of  claim 149 , wherein the fungus is selected from the group consisting of  Aspergillus, Blastomyces dermatitidis, Candida, Coccidioides immitis, Cryptococcus neoformans, Histoplasma capsulatum var. capsulatum, Paracoccidioides brasiliensis, Sporothrix schenckii, Zygomycetes  spp.,  Absidia corymbifera, Rhizomucor pusillus,  and  Rhizopus arrhizus.    
     
     
         153 . The method of  claim 149 , wherein the parasite is selected from the group consisting of  Toxoplasma gondii, Plasmodium falciparum, P. vivax, P. ovale, P. malariae, Trypanosoma  spp., and  Legionella  spp. 
     
     
         154 . The method of  claim 1 , wherein the disease is selected from the group consisting of hypertension, hyperglycemia, hyperlipidemia, edema, depression, obesity, infertility, amenorrhea, fatigue, vertigo, uterine bleeding, uterine ulcer, hyperthyroidism, myoma, endometriosis, cerebral palsy, brain atrophy, systemic muscular atrophy, trigeminal neuralgia, schizophrenia, epilepsy, amyotrophic lateral sclerosis (ALS), Parkinson's Disease, autism, Alzheimer's Disease, Huntington's Disease, emphysema, asthma, hepatitis B, cough, systemic fibroma, renal diseases, lung diseases, and liver diseases. 
     
     
         155 . The method of  claim 1 , wherein the subject is a mammal. 
     
     
         156 . The method of  claim 155 , wherein the mammal is a human. 
     
     
         157 . A kit comprising a clamp and a package insert instructing a user of said kit to treat a subject according to the method of  claim 1 . 
     
     
         158 . The kit of  claim 157 , wherein the clamp comprises a regulator screw capable of maintaining a desired distance between arms of said clamp. 
     
     
         159 . The kit of  claim 158 , wherein the regulator screw can be adjusted to one of a plurality of settings. 
     
     
         160 . The kit of  claim 159 , wherein the plurality of settings correspond to a state of maximum distance between the arms of said clamp, one or more states of intermediate distance between the arms of said clamp, and a state of minimum distance between the arms of said clamp. 
     
     
         161 . The kit of  claim 160 , wherein the setting that corresponds to said state of maximum distance between the arms of said clamp is indicated by exposure of a green color adjacent to an arm of said clamp. 
     
     
         162 . The kit of  claim 160 , wherein the setting that corresponds to said state of intermediate distance between the arms of said clamp is indicated by exposure of a yellow color adjacent to an arm of said clamp. 
     
     
         163 . The kit of  claim 160 , wherein the setting that corresponds to said state of minimum distance between the arms of said clamp is indicated by exposure of a red color adjacent to an arm of said clamp.

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